Evidence map›Paper›PMID 24561207›Full record

Trial reportAnnals of vascular surgery2014

Prospective randomized trial of ACUSEAL versus Vascu-Guard patching in carotid endarterectomy.

Patrick A Stone, Ali F AbuRahma, Albeir Y Mousa, David Phang, Stephen M Hass, Asmita Modak, David Dearing

Registry-linked trialOpen access · greenAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of vascular surgery, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01184183 (Prospective Randomized Trial Comparison of Accuseal and Bovine Pericardial Patch During Endarterectomy), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01184183 completednot on this map

Prospective Randomized Trial Comparison of Accuseal and Bovine Pericardial Patch During Endarterectomy

TypeobservationalSponsorCAMC Health SystemRan2009 to 2012Enrolled200ConditionsCoronary StenosisArmsComparing Accuseal Vs. Bovine Pericardial in CEA
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Patches of different types for carotid patch angioplasty.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Article
  3. Observational
  4. Review
  5. Extracellular Matrix Patches for Endarterectomy Repair.Frontiers in cardiovascular medicine · 2021
    Article
  6. Review
  7. Comparative Review of the Treatment Methodologies of Carotid Stenosis.The International journal of angiology : official publication of the International College of Angiology, Inc · 2015
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Patrick A StoneDepartment of Surgery, Robert C. Byrd Health Sciences Center of West Virginia University, Charleston, WV. Electronic address: pstone@camc.org.
Ali F AbuRahmaDepartment of Surgery, Robert C. Byrd Health Sciences Center of West Virginia University, Charleston, WV.
Albeir Y MousaDepartment of Surgery, Robert C. Byrd Health Sciences Center of West Virginia University, Charleston, WV.
David PhangDepartment of Surgery, Robert C. Byrd Health Sciences Center of West Virginia University, Charleston, WV.
Stephen M HassDepartment of Surgery, Robert C. Byrd Health Sciences Center of West Virginia University, Charleston, WV.
Asmita ModakDepartment of Surgery, Division of Vascular and Endovascular Surgery, Charleston Area Medical Center: Health Education and Research Institute, Charleston, WV.
David DearingDepartment of Surgery, Robert C. Byrd Health Sciences Center of West Virginia University, Charleston, WV.
Charleston Area Medical Center · USWest Virginia University · US

Funding

West Virginia IDEA-CTRU54GM104942 · NIGMS · WEST VIRGINIA UNIVERSITY · PI Sally Lynn Hodder · 2012 to 2026
$81.0M
NIGMS NIH HHS U54 GM104942
6 · The paper itself

Abstract

backgroundMultiple studies have been conducted that demonstrate the superiority of patch angioplasty over primary closure for carotid endarterectomy (CEA). Patch angioplasty with polytetrafluorethylene patches (ACUSEAL) have shown results comparable to patch angioplasty with saphenous vein and polyester patches. This is a prospective randomized study to compare the clinical outcomes of CEA using ACUSEAL versus bovine pericardium patching (Vascu-Guard).

methodsTwo hundred patients were randomized (1:1) to either ACUSEAL or Vascu-Guard patching. Demographic data/clinical characteristics were collected. Intraoperative hemostasis times and the frequency of reexploration for neck hematoma were recorded. All patients received immediate and 1-month postoperative duplex ultrasound studies, which were repeated at 6-month intervals. A Kaplan-Meier analysis was used to estimate the risk of restenosis and the stroke-free survival rates.

resultsThe demographics were similar in both groups, except for a higher incidence of current smokers in the ACUSEAL group and more patients with congestive heart failure in the Vascu-Guard group (P = 0.02 and 0.03, respectively). The mean operative internal carotid artery diameter and the mean arteriotomy length were similar in both groups. The mean hemostasis time was 4.90 min for ACUSEAL patching vs. 3.09 min for Vascu-Guard (P = 0.027); however, the mean operative times were similar for both groups (ACUSEAL 2.09 hr vs. Vascu-Guard 2.16 hr, P = 0.669). The incidence of reexploration for neck hematoma was higher in the Vascu-Guard group; 6.12% vs. 1.03% (P = 0.1183). The incidence of perioperative ipsilateral neurologic events was 3.09% for ACUSEAL patching vs. 1.02% for Vascu-Guard patching (P = 0.368). The mean follow-up period was 15 months. The respective freedom from ≥70% carotid restenosis at 1, 2, and 3 years were 100%, 100%, and 100% for ACUSEAL patching vs. 100%, 98%, and 98% for Vascu-Guard patching (P = 0.2478). The ipsilateral stroke-free rates at 1, 2, and 3 years were 96% for ACUSEAL and 99% for Vascu-Guard patching.

conclusionsAlthough CEA patching with ACUSEAL versus Vascu-Guard differed in hemostasis time, the frequency of reexploration for neck hematomas was more frequent in the pericardial patch group; however, only 1 patient had documented suture line bleeding and the surgical reexploration rate is not likely to be patch related. There were not any significant differences in perioperative/late neurologic events and late restenosis in the 2 groups.

Indexed as

Endarterectomy, CarotidPolytetrafluoroethyleneAdultAgedAged, 80 and overAngioplastyAnimalsCarotid Artery, InternalCarotid StenosisCattleFemaleHematomaHemostasis, SurgicalHeterograftsHumansKaplan-Meier EstimatePolytetrafluoroethylene

Identifiers

PMID24561207
PMCPMC4554324
OpenAlexW2081059945

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.